Zinbryta: which tox species, and why?

“General toxicity studies were conducted in cynomolgus monkey, the only pharmacologically relevant species.”

“DAC-HYP had no pharmacological effect on primary lymphocytes isolated from rats or mice. Plasmon surface resonance revealed comparable affinity of DAC-HYP for human (KD = 0.49 nM) and monkey (KD = 0.42 nM) CD25.”

“There was no pharmacological activity in primary lymphocytes isolated from rodents. All in vivo toxicology studies were, therefore, conducted in cynomolgus monkeys.”

“General toxicity studies were conducted in cynomolgus monkey, the only pharmacologically relevant species.”

“Pharmacokinetic (PK)/toxicokinetic (TK) profiles of daclizumab were comprehensively evaluated in single dose intravenous IV and single and repeat-dose SC studies (acute, sub-chronic, chronic, reproductive, embryo-foetal, and pre- and post-natal toxicology studies) in cynomolgus monkeys.”

“Because DAC HYP is pharmacologically active only in monkey, carcinogenicity studies are not feasible; therefore, the carcinogenic potential of DAC HYP was not assessed.”

“There was no pharmacological activity in primary lymphocytes isolated from rodents. All in vivo toxicology studies were, therefore, conducted in cynomolgus monkeys.”